Field
The present specification generally relates to pharmaceutical glass containers and, more specifically, to pharmaceutical glass containers which greatly reduce particle generation during processing, for example, during processing in pharmaceutical filling lines
Technical Background
Particle contamination, especially in parenteral drugs, poses a risk to patient safety and, despite being monitored closely during pharmaceutical manufacturing, glass and metal particles continue to be a leading cause of parenteral drug recalls. With traditional glass containers, glass-to-glass contact produces significant quantities of particle of various sizes in the most sensitive portion of the filling process (i.e., prior to container closure).
During processing in bulk, high speed pharmaceutical filling lines, conventional borosilicate glass containers are subjected to systematic glass to glass contact due to the handling method designs. Operations such as loading, accumulation, rotary drives, star wheels and singulation place containers under load while they are in contact with one another. A number of the operations take place following washing, but before capping where the container is susceptible to glass to glass to damage. Furthermore, the glass is depyrogenated and cleaned, further increasing the surface coefficient of friction and susceptibility and severity of the damage. The damage that is caused from glass to glass contact results in glass particle generation. Depending on the nature of the damage, impact loads and presence of pre-existing damage, glass particles ranging from 1 to 120 μm can be generated. If these particles are being generated in the filling line environment, there exists a risk that the particles can contaminate open containers. The design of the filling line area and laminar air flow does not fully prevent such airborne contamination.
The United States Pharmacopoeia (USP) has defined limits on allowable particle levels. The allowable level for visible particles is zero. Visible particles are defined by the ability for a certified operator to detect the particle in the solution with the unaided eye with specific lighting conditions. <USP 1 and USP 790>. Generally, particles in the 50 to 150 μm range is the threshold for reliable visible detection. USP has regulations for sub-visible particle levels as well. <USP 788> defines levels of 600 and 6000 particles per dose for particles size >25 μm and >10 μm respectively. Particle generation in pharmaceutical filling lines can make containers non-compliant with USP standards.
Accordingly, a need exists for improved pharmaceutical glass containers which reduce particle generation in pharmaceutical filling lines.